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Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised controlled trial study protocol

INTRODUCTION: Clostridioides difficile is the leading cause of healthcare-associated infections in the USA, with an estimated 1 billion dollars in excess cost to the healthcare system annually. C. difficile infection (CDI) has high recurrence rate, up to 25% after first episode and up to 60% for suc...

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Autores principales: Warren, Cirle A, Shin, Jae Hyun, Bansal, Ekta N, Costa, Deiziane V D S, Wang, Xin Qun, Wu, Martin, Swann, Jonathan R, Behm, Brian W, Targonski, Paul V, Archbald-Pannone, Laurie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10357635/
https://www.ncbi.nlm.nih.gov/pubmed/37474181
http://dx.doi.org/10.1136/bmjopen-2023-075721
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author Warren, Cirle A
Shin, Jae Hyun
Bansal, Ekta N
Costa, Deiziane V D S
Wang, Xin Qun
Wu, Martin
Swann, Jonathan R
Behm, Brian W
Targonski, Paul V
Archbald-Pannone, Laurie
author_facet Warren, Cirle A
Shin, Jae Hyun
Bansal, Ekta N
Costa, Deiziane V D S
Wang, Xin Qun
Wu, Martin
Swann, Jonathan R
Behm, Brian W
Targonski, Paul V
Archbald-Pannone, Laurie
author_sort Warren, Cirle A
collection PubMed
description INTRODUCTION: Clostridioides difficile is the leading cause of healthcare-associated infections in the USA, with an estimated 1 billion dollars in excess cost to the healthcare system annually. C. difficile infection (CDI) has high recurrence rate, up to 25% after first episode and up to 60% for succeeding episodes. Preliminary in vitro and in vivo studies indicate that alanyl-glutamine (AQ) may be beneficial in treating CDI by its effect on restoring intestinal integrity in the epithelial barrier, ameliorating inflammation and decreasing relapse. METHODS AND ANALYSIS: This study is a randomised, placebo-controlled, double-blind, phase II clinical trial. The trial is designed to determine optimal dose and safety of oral AQ at 4, 24 and 44 g doses administered daily for 10 days concurrent with standard treatment of non-severe or severe uncomplicated CDI in persons age 18 and older. The primary outcome of interest is CDI recurrence during 60 days post-treatment follow-up, with the secondary outcome of mortality during 60 days post-treatment follow-up. Exploratory analysis will be done to determine the impact of AQ supplementation on intestinal and systemic inflammation, as well as intestinal microbial and metabolic profiles. ETHICS AND DISSEMINATION: The study has received University of Virginia Institutional Review Board approval (HSR200046, Protocol v9, April 2023). Findings will be disseminated via conference presentations, lectures and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT04305769.
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spelling pubmed-103576352023-07-21 Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised controlled trial study protocol Warren, Cirle A Shin, Jae Hyun Bansal, Ekta N Costa, Deiziane V D S Wang, Xin Qun Wu, Martin Swann, Jonathan R Behm, Brian W Targonski, Paul V Archbald-Pannone, Laurie BMJ Open Research Methods INTRODUCTION: Clostridioides difficile is the leading cause of healthcare-associated infections in the USA, with an estimated 1 billion dollars in excess cost to the healthcare system annually. C. difficile infection (CDI) has high recurrence rate, up to 25% after first episode and up to 60% for succeeding episodes. Preliminary in vitro and in vivo studies indicate that alanyl-glutamine (AQ) may be beneficial in treating CDI by its effect on restoring intestinal integrity in the epithelial barrier, ameliorating inflammation and decreasing relapse. METHODS AND ANALYSIS: This study is a randomised, placebo-controlled, double-blind, phase II clinical trial. The trial is designed to determine optimal dose and safety of oral AQ at 4, 24 and 44 g doses administered daily for 10 days concurrent with standard treatment of non-severe or severe uncomplicated CDI in persons age 18 and older. The primary outcome of interest is CDI recurrence during 60 days post-treatment follow-up, with the secondary outcome of mortality during 60 days post-treatment follow-up. Exploratory analysis will be done to determine the impact of AQ supplementation on intestinal and systemic inflammation, as well as intestinal microbial and metabolic profiles. ETHICS AND DISSEMINATION: The study has received University of Virginia Institutional Review Board approval (HSR200046, Protocol v9, April 2023). Findings will be disseminated via conference presentations, lectures and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT04305769. BMJ Publishing Group 2023-07-19 /pmc/articles/PMC10357635/ /pubmed/37474181 http://dx.doi.org/10.1136/bmjopen-2023-075721 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Research Methods
Warren, Cirle A
Shin, Jae Hyun
Bansal, Ekta N
Costa, Deiziane V D S
Wang, Xin Qun
Wu, Martin
Swann, Jonathan R
Behm, Brian W
Targonski, Paul V
Archbald-Pannone, Laurie
Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised controlled trial study protocol
title Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised controlled trial study protocol
title_full Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised controlled trial study protocol
title_fullStr Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised controlled trial study protocol
title_full_unstemmed Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised controlled trial study protocol
title_short Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised controlled trial study protocol
title_sort alanyl-glutamine supplementation for clostridioides difficile infection treatment (act): a double-blind randomised controlled trial study protocol
topic Research Methods
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10357635/
https://www.ncbi.nlm.nih.gov/pubmed/37474181
http://dx.doi.org/10.1136/bmjopen-2023-075721
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